风险评估和缓解战略 (REMS) 公共仪表板:提高监管活动的透明度
Gita A Toyserkani1, Joann H Lee2, Esther H Zhou2
1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 1106, Silver Spring, MD, 20993, USA. Gita.Toyserkani@fda.hhs.gov.
Pharmaceutical medicine
|July 8, 2023
概括
美国食品和药物管理局 (FDA) 推出了REMS公共仪表板,以便轻松访问药物安全信息. 该工具帮助医疗保健提供者,患者和研究人员可视化风险评估和缓解策略 (REMS) 数据.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全条例 药物安全条例
- 医疗信息学 医疗信息学
背景情况:
- 风险评估和缓解策略 (REMS) 对于管理药物风险至关重要.
- 获取全面的REMS信息一直是利益相关者面临的挑战.
- 美国食品和药物管理局 (FDA) 试图改善公众对REMS数据的访问.
研究的目的:
- 描述FDA的REMS公共仪表板的功能和可访问性.
- 强调仪表板对包括医疗保健提供者,患者和研究人员在内的各种利益相关者的实用性.
- 通知用户关于REMS程序详细信息和趋势的可用性.
主要方法:
- 使用Qlik Sense®开发一个交互式,基于Web的工具.
- 包含八个不同的页面,涵盖REMS程序的各个方面 (例如,主动,修改,共享系统).
- 基于REMS特征和批准时间表 (2008年至今) 的数据可视化和分层能力的实施.
主要成果:
- 雷姆斯公共仪表板提供了一个用户友好的平台,可以访问和可视化雷姆斯信息.
- 仪表板允许详细检查REMS程序,包括修改和修订.
- 用户可以通过交互式数据探索来分析趋势和特定程序细节.
结论:
- 美国食品和药物管理局REMS公共仪表板提高了关键药物安全信息的透明度和可访问性.
- 互动工具支持医疗保健专业人员,患者和研究人员的知情决策.
- 该平台有助于识别与药物安全相关的新兴研究和监管问题.
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